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OpenTrials
Completed

NCT Number: NCT00848354

Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy

The purpose of this 2 phased, open-label study is to compare the safety and efficacy of etanercept with conventional Disease Modifying Antirheumatic Drug (DMARD) therapy in Latin American subjects with moderate to severe rheumatoid arthritis over 128 weeks. Phase 1 is a randomized 24 week treatment period; Phase 2 is an optional open-label 104 week period that allows the investigator to choose continuation with the phase I treatment or the addition, discontinuation or titration of other DMARD therapy already being utilized for the study.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigaciones Reumatológicas y Osteológicas, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Rheumatoid Arthritis (RA)
  • Currently receiving a suboptimal response to a stable dose of methotrexate for treatment of Rheumatoid Arthritis (RA)
  • Active Rheumatoid Arthritis (RA) at time of screening and baseline

Exclusion criteria

  • Previous or current treatment with etanercept, other tumor necrosis factor-alpha inhibitors, or other biologic agents
  • Concurrent treatment with a Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, at screening
  • Receipt of any Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, within 3 months before screening

Treatment and study plan

Phase 1: Etanercept

Biological

Phase 1: prefilled syringe 50mg/ml, administered once weekly for study weeks 0 - 24

Other names: Enbrel

Phase 1: Methotrexate

Drug

Phase 1: oral tablet, 2.5mg, dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.

Phase 2: Optional ETN, SSZ, HCQ, MTX

Drug

Phase 2: All therapies are optional and may include any combination of the following: ETN, SSZ, HCQ, MTX Phase 2: Optional ETN: prefilled syringe 50mg/ml, dose variable after study week 24 to week 128.

Phase 2: Optional SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations after study week 24 to week 128.

Phase 2: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations after study week 24 to week 128.

Phase 2: MTX: oral tablet, 2.5mg dose variable after week 24 to week 128.

Phase 1: Conventiaonal DMARD

Drug

Phase 1: SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations. OR Phase 1: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations.

Primary outcomes

  1. Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24

    Time frame: Week 24

    ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of the Health Assessment Questionnaire; HAQ); and C-Reactive Protein (CRP).

Secondary outcomes

  1. Change From Baseline in HAQ Score at Week 24

    Time frame: Baseline and Week 24

    HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty: 0, with some difficulty: 1, with much difficulty: 2, unable to do: 3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25: normal functioning; 0.25-0.5: mild functional limitation; 0.5-1: moderate functional limitation; more than 1: significant functional limitation.

  2. Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24

    Time frame: Baseline and Week 24

    The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.

  3. Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdH mTSS), Annualized, at Week 24

    Time frame: Baseline and Week 24

    mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.

  4. Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour; mm/hour) and the participant's general health using a 100 mm-visual analog scale (VAS). DAS28<3.2 indicates low disease activity and DAS28<2.6 remission.

  5. Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the ESR (mm/hour) and the participant's general health using a 100 mm-VAS. DAS28<3.2 indicates low disease activity and DAS28<2.6 remission.

  6. Summary of Changes in Therapy at the Beginning of Phase 2

    Time frame: Week 24

    The investigators were allowed to alter each participant's therapy at the beginning of Phase 2. Continuations, discontinuations and additions made to Phase 1 treatment regimen were summarized.

  7. Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20

    ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP.

  8. Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR.

  9. Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    ACR20 response: greater than or equal to 20 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 20 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP.

  10. Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    ACR20 response: greater than or equal to 20 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 20 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR.

  11. Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    ACR70 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 70 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP.

  12. Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    ACR70 response: greater than or equal to 70 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 70 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR.

  13. Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    DAS calculated from number of painful joints using the ritchie articular index (RAI), number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS≤2.4 indicates low disease activity and DAS<1.6 remission.

  14. Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS≤2.4 indicates low disease activity and DAS<1.6 remission.

  15. Percentage of Participants Achieving DAS<2.4 (Low Disease Activity) Response at Week 24

    Time frame: Week 24

    DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.

  16. Percentage of Participants Achieving DAS<1.6 (Remission) Response at Week 24

    Time frame: Week 24

    DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.

  17. Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.

  18. Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.

  19. Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.

  20. Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.

  21. Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS-based EULAR response was defined as:

    • DAS-value ≤3.7 and DAS-improvement from Baseline >0.6
    • DAS-value >3.7 and DAS-improvement from Baseline >1.2

  22. Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS-based EULAR response was defined as:

    • DAS-value ≤3.7 and DAS-improvement from Baseline >0.6
    • DAS-value >3.7 and DAS-improvement from Baseline >1.2

  23. Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS-based EULAR response was defined as: DAS-value ≤2.4 and DAS-improvement from Baseline >1.2.

  24. Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS-based EULAR response was defined as: DAS-value ≤2.4 and DAS-improvement from Baseline >1.2.

  25. Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS28-based EULAR response was defined as:

    • DAS28-value ≤5.1 and DAS28-improvement from Baseline >0.6
    • DAS28-value >5.1 and DAS28-improvement from Baseline >1.2

  26. Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS28-based EULAR response was defined as:

    • DAS28-value ≤5.1 and DAS28-improvement from Baseline >0.6
    • DAS28-value >5.1 and DAS28-improvement from Baseline >1.2

  27. Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS28-based EULAR response was defined as: DAS28-value ≤3.2 and DAS28-improvement from Baseline >1.2.

  28. Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS28-based EULAR response was defined as: DAS28-value ≤3.2 and DAS28-improvement from Baseline >1.2.

  29. Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.

  30. Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.

  31. Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.

  32. Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.

  33. Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.

  34. Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.

  35. Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.

  36. Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.

  37. Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Painful joint count is a physical assessment of the ACR-specified 68 joint set for tenderness/pain. Each joint is rated as either painful or not painful with the total number of painful joints reported as the score. Score range is from 0-68 with lower scores indicating the better outcome.

  38. Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Painful joint count is a physical assessment of the ACR-specified 68 joint set for tenderness/pain. Each joint is rated as either painful or not painful with the total number of painful joints reported as the score. Score range is from 0-68 with lower scores indicating the better outcome.

  39. Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Swollen joint count is a physical assessment of the ACR-specified 66 joint set for swelling. Each joint is rated as either swollen or not swollen with the total number of swollen joints reported as the score. Score range is from 0-66 with lower scores indicating the better outcome.

  40. Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Swollen joint count is a physical assessment of the ACR-specified 66 joint set for swelling. Each joint is rated as either swollen or not swollen with the total number of swollen joints reported as the score. Score range is from 0-66 with lower scores indicating the better outcome.

  41. Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    The participant's global disease activity was estimated over the preceding 2-3 days on a scale from 0 (no disease activity) to 10 (extreme disease activity) by the physician.

  42. Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    The participant's global disease activity was estimated over the preceding 2-3 days on a scale from 0 (no disease activity) to 10 (extreme disease activity) by the physician.

  43. Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    The participant assessed overall arthritis activity on a scale from 0 (no disease activity) to 10 (extreme disease activity).

  44. Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    The participant assessed overall arthritis activity on a scale from 0 (no disease activity) to 10 (extreme disease activity).

  45. Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    The duration of morning stiffness was determined over the preceding 2 days using a 2-question worksheet.

  46. Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    The duration of morning stiffness was determined over the preceding 2 days using a 2-question worksheet.

  47. Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    The participants had to indicate on a 100 mm-VAS (0 mm: very well, 100 mm: extremely bad) in general how they rated their health over the preceding 2-3 weeks.

  48. Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    The participants had to indicate on a 100 mm-VAS (0 mm: very well, 100 mm: extremely bad) in general how they rated their health over the preceding 2-3 weeks.

  49. Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    The participants had to indicate on a 100 mm-VAS (0 mm: no pain, 100 mm: pain as bad as it could be) the amount of pain they experienced over the preceding 2-3 days.

  50. Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    The participants had to indicate on a 100 mm-VAS (0 mm: no pain, 100 mm: pain as bad as it could be) the amount of pain they experienced over the preceding 2-3 days.

  51. Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    The participants had to indicate on a 100 mm-VAS (0 mm: no fatigue, 100 mm: a great deal of fatigue) how much of a problem had fatigue or tiredness been for them in the preceding week.

  52. Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    The participants had to indicate on a 100 mm-VAS (0 mm: no fatigue, 100 mm: a great deal of fatigue) how much of a problem had fatigue or tiredness been for them in the preceding week.

  53. Change From Baseline in Joint Space Narrowing Score Using vdH mTSS at Week 24

    Time frame: Week 24

    mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.

  54. Change From Baseline in Erosion Score Using vdH mTSS at Week 24

    Time frame: Week 24

    mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.

  55. Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation. ESR was performed at the investigative site using an ESR kit supplied by the centralized laboratory.

  56. Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

    ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation. ESR was performed at the investigative site using an ESR kit supplied by the centralized laboratory.

  57. Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

    The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. CRP was analysed at a central laboratory.

  58. Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 8, Week 16, and Week 24

    Time frame: Week 8, Week 16, and Week 24

    The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.

  59. Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 50, Week 76, Week 102, and Week 128

    Time frame: Week 50, Week 76, Week 102, and Week 128

    The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.

  60. Change From Baseline in SF-36 Health Survey Mental Component Score at Week 8, Week 16, and Week 24

    Time frame: Week 8, Week 16, and Week 24

    The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.

  61. Change From Baseline in SF-36 Health Survey Mental Component Score at Week 50, Week 76, Week 102, and Week 128

    Time frame: Week 50, Week 76, Week 102, and Week 128

    The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.

  62. Change From Baseline in SF-36 Health Survey Physical Component Score at Week 8, Week 16, and Week 24

    Time frame: Week 8, Week 16, and Week 24

    The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.

  63. Change From Baseline in SF-36 Health Survey Physical Component Score at Week 50, Week 76, Week 102, and Week 128

    Time frame: Week 50, Week 76, Week 102, and Week 128

    The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.

  64. Change From Baseline in SF-36 Health Survey Bodily Pain Domain Score at Week 8, Week 16, and Week 24

    Time frame: Week 8, Week 16, and Week 24

    The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.

  65. Change From Baseline in SF-36 Health Survey Role Limitations Due to Emotional Problems Domain Score at Week 8, Week 16, and Week 24

    Time frame: Week 8, Week 16, and Week 24

    The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.

  66. Change From Baseline in SF-36 Health Survey General Health Perceptions Domain Score at Week 8, Week 16, and Week 24

    Time frame: Week 8, Week 16, and Week 24

    The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.

  67. Change From Baseline in SF-36 Health Survey Mental Health Domain Score at Week 8, Week 16, and Week 24

    Time frame: Week 8, Week 16, and Week 24

    The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.

  68. Change From Baseline in SF-36 Health Survey Physical Functioning Domain Score at Week 8, Week 16, and Week 24

    Time frame: Week 8, Week 16, and Week 24

    The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.

  69. Change From Baseline in SF-36 Health Survey Role Limitations Due to Physical Health Domain Score at Week 8, Week 16, and Week 24

    Time frame: Week 8, Week 16, and Week 24

    The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.

  70. Change From Baseline in SF-36 Health Survey Social Functioning Domain Score at Week 8, Week 16, and Week 24

    Time frame: Week 8, Week 16, and Week 24

    The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Amgen

Registry information

Official study title

A Randomized, Open-label Study In The Latin America Region Comparing The Safety And Efficacy Of Etanercept With Conventional Dmard Therapy In Subjects With Rheumatoid Arthritis.

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Feb 20, 2009
Registry last updated
Jan 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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